U.S. patent application number 12/450439 was filed with the patent office on 2010-02-04 for barrier membranes for guided bone regeneration.
This patent application is currently assigned to YESBIO CO., LTD.. Invention is credited to Doug-Youn Lee, Sang-Bae Lee, Jeong-Jong Park, Kyeong-Jun Park.
Application Number | 20100028409 12/450439 |
Document ID | / |
Family ID | 40150247 |
Filed Date | 2010-02-04 |
United States Patent
Application |
20100028409 |
Kind Code |
A1 |
Lee; Doug-Youn ; et
al. |
February 4, 2010 |
Barrier Membranes For Guided Bone Regeneration
Abstract
A barrier membrane for guided bone regeneration and a method of
manufacturing the same are provided. The barrier membrane for
guided bone regeneration that is made of silver, gold, or gold
alloy includes a substrate having texture including protrusions
with a predetermined shape, a polymer layer formed by coating an
upper surface of the substrate with polymer solution, and a
bio-ceramic layer formed by coating a lower surface of the
substrate. It is possible for the barrier membrane for guided bone
regeneration to secure biocompatibility, exclusion and sealing of
cells, space maintenance, connectivity with tissues, and easiness
of using the barrier membrane which are required for guided
bone/tissue regeneration (GBR/GTR).
Inventors: |
Lee; Doug-Youn;
(Gyeonggi-do, KR) ; Lee; Sang-Bae; (Gyeonggi-do,
KR) ; Park; Kyeong-Jun; (Gyeonggi-do, KR) ;
Park; Jeong-Jong; (Gyeonggi-do, KR) |
Correspondence
Address: |
THE NATH LAW GROUP
112 South West Street
Alexandria
VA
22314
US
|
Assignee: |
YESBIO CO., LTD.
Goyang-si, Gyeonggi-do
KR
|
Family ID: |
40150247 |
Appl. No.: |
12/450439 |
Filed: |
March 17, 2008 |
PCT Filed: |
March 17, 2008 |
PCT NO: |
PCT/KR2008/001500 |
371 Date: |
September 25, 2009 |
Current U.S.
Class: |
424/443 ;
433/215; 623/23.61 |
Current CPC
Class: |
A61L 31/022 20130101;
A61L 31/082 20130101 |
Class at
Publication: |
424/443 ;
433/215; 623/23.61 |
International
Class: |
A61F 2/28 20060101
A61F002/28; A61C 8/00 20060101 A61C008/00; A61K 9/70 20060101
A61K009/70 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 26, 2007 |
KR |
10-2007-0029058 |
Mar 14, 2008 |
KR |
10-2008-0023982 |
Claims
1. A barrier membrane for guided bone and tissue regeneration
comprising a substrate having a previously set thickness, wherein
the substrate is made of gold, silver, or gold alloy obtained by
adding an one element of platinum (Pt), palladium (Pd), silver
(Ag), copper (Cu), iridium (Ir), zinc (Zn), indium (In), rhodium
(Rh) and tin (Sn) to gold, and wherein the substrate has texture
with arbitrary shapes.
2. A barrier membrane for guided bone and tissue regeneration
comprising a substrate having a previously set thickness, wherein
the substrate is made of gold, silver, or gold alloy obtained by
adding an one element of platinum (Pt), palladium (Pd), silver
(Ag), copper (Cu), iridium (Ir), zinc (Zn), indium (In), rhodium
(Rh) and tin (Sn) to gold.
3. The barrier membrane for guided bone and tissue regeneration
according to claim 1, further comprising a polymer layer containing
an antibiotic on an upper surface of the substrate.
4. The barrier membrane for guided bone and tissue regeneration
according to claim 1, further comprising a bio-ceramic layer
obtained by coating a lower surface of the substrate with
bio-ceramic.
5. The barrier membrane for guided bone and tissue regeneration
according to claim 1, wherein the texture includes a plurality of
protrusions and protruded pores, and wherein the protruded pores
pass through the upper and lower surfaces of the substrate.
6. The barrier membrane for guided bone and tissue regeneration
according to claim 4, wherein the bio-ceramic layer is formed by
coating the lower surface of the substrate with a material selected
from the group consisting of hydroxyapatite (HA), .beta.-tricalcium
phosphate (.beta.-TCP), bioglass, and gypsum by spraying the
material onto the lower surface in high pressure.
7. The barrier membrane for guided bone and tissue regeneration
according to claim 4, wherein the bio-ceramic layer is made of a
material selected from the group consisting of hydroxyapatite (HA),
.beta.-tricalcium phosphate (.beta.-TCP), bioglass, and gypsum, and
wherein the bio-ceramic layer is attached to the lower surface of
the substrate by using a polymer material having adhesive force
with the selected material.
8. The barrier membrane for guided bone regeneration according to
claim 1, wherein the substrate is rolled so as to have the
previously set thickness.
9. The barrier membrane for guided bone and tissue regeneration
according to claim 2, further comprising a polymer layer containing
an antibiotic on an upper surface of the substrate.
10. The barrier membrane for guided bone and tissue regeneration
according to claim 2, further comprising a bio-ceramic layer
obtained by coating a lower surface of the substrate with
bio-ceramic.
11. The barrier membrane for guided bone and tissue regeneration
according to claim 10, wherein the bio-ceramic layer is formed by
coating the lower surface of the substrate with a material selected
from the group consisting of hydroxyapatite (HA), .beta.-tricalcium
phosphate (.beta.-TCP), bioglass, and gypsum by spraying the
material onto the lower surface in high pressure.
12. The barrier membrane for guided bone and tissue regeneration
according to claim 10 wherein the bio-ceramic layer is made of a
material selected from the group consisting of hydroxyapatite (HA),
.beta.-tricalcium phosphate (.beta.-TCP), bioglass, and gypsum, and
wherein the bio-ceramic layer is attached to the lower surface of
the substrate by using a polymer material having adhesive force
with the selected material.
13. The barrier membrane for guided bone regeneration according to
claim 2, wherein the substrate is rolled so as to have the
previously set thickness.
Description
TECHNICAL FIELD
[0001] The present invention relates to a barrier membrane for
guided bone and tissue regeneration, and more particularly, a
barrier membrane for guided bone and tissue regeneration capable of
securing biocompatibility, exclusion and sealing of cells, space
maintenance, connectivity with tissues, and easiness of using the
barrier membrane by forming a polymer layer and a bio-ceramic layer
respectively on upper and lower surfaces of a substrate made of
gold (Au) which has texture including protrusions with
predetermined shapes.
BACKGROUND ART
[0002] In order to regenerate tissues destroyed and disappeared due
to periodontal diseases, a surgical operation or non-surgical
operation may be performed. Bone graft and guided tissue
regeneration (GTR) for regenerating the destroyed periodontal
tissues are clinically performed as the surgical operation.
However, in a case where bones are damaged due to the periodontal
diseases, an alveolar bone is not recovered by attaching the
epithelium through a simple periodontal curettage or operation.
Accordingly, the GTR for guiding formation of bone by using a
barrier membrane for periodontal tissue regeneration has been
widely employed.
[0003] The GTR that has been clinically used since 1986 is referred
to regeneration of a new periodontal ligament formed by cells
originated from a periodontal ligament which is attached to new
cementum. In the GTR, gingival epitheliums and connective tissues
are excluded by inserting a barrier membrane between a root surface
and a valve which are cleansed when performing flap surgery, and it
is possible to attach new periodontal tissues by moving only
periodontal ligament cells and periodontal bone cells under a
wounded part to the wounded part. The barrier membrane is used for
the aforementioned regeneration. The barrier membrane is used to
prevent epithelium cells from moving to a root apex, prevents
gingival fibers from penetrating into a damaged part, and induces
growth of cells from periodontal ligaments and a periodontal
bone.
[0004] The barrier membrane used for the GTR may be divided into
absorbent and unabsorbent barrier membranes.
[0005] Since a structure and strength of the unabsorbent barrier
membrane is maintained when the unabsorbent barrier membrane exists
in tissues, it is possible to completely control the unabsorbent
barrier membrane after the GTR. The unabsorbent barrier membrane
secures a relatively constant clinical effect. However, the
unabsorbent barrier membrane has to be removed after the GTR. When
the unabsorbent barrier membrane is not removed, an inflammation of
new tissues may be caused by the unabsorbent barrier membrane.
Expanded polytetrafluoroethylene (e-PTFE) that is a material of a
Gore-tex regenerative membrane of Gore medical corporation in the
USA may be used for the unabsorbent barrier membrane. However,
since the Gore-tex regenerative membrane is very expensive, the
Gore-tex regenerative membrane has not been widely used.
[0006] On the other hand, the absorbent barrier membrane
accommodates patients without an additional operation for removing
the absorbent barrier membrane, thereby reducing costs.
Accordingly, recently, research on the absorbent barrier membrane
has been actively performed. However, reaction of tissues may be
unavoidably caused due to resolvability of the absorbent barrier
membrane in a human body. In case of a material with high
absorptivity, an inflammation reaction may occur. In addition, it
is advantageous that the absorbent barrier membrane is resolved in
the human body. The absorbent barrier membrane is deficient in
strength and shape allowance. Thus, the absorbent barrier membrane
dose not satisfy a condition that a structure with a predetermined
shape (in vivo structure) has to be maintained in the human body
for 4 to 6 weeks based on a biological principle.
[0007] Accordingly, a barrier membrane that secures
biocompatibility, exclusion and sealing of cells, space
maintenance, connectivity with tissues, and easiness of using the
barrier membrane is requested to be developed.
DISCLOSURE
Technical Problem
[0008] The present invention provides a barrier membrane for guided
bone regeneration that is an unabsorbent barrier layer that secures
biocompatibility, exclusion and sealing of cells, space
maintenance, connectivity with tissues, and easiness of using the
barrier membrane
Technical Solution
[0009] According to a first aspect of the present invention, there
is provided a barrier membrane for guided bone regeneration
comprising a substrate having a previously set thickness, wherein
the substrate is made of gold, silver, or gold alloy obtained by
adding an element such as platinum (Pt), palladium (Pd), silver
(Ag), copper (Cu), iridium (Ir), zinc (Zn), indium (In), rhodium
(Rh), tin (Sn), and the like to gold, and wherein the substrate has
texture with arbitrary shapes.
[0010] According to a second aspect of the present invention, there
is provided a barrier membrane for guided bone regeneration
comprising a substrate having a previously set thickness, wherein
the substrate is made of gold, silver, or gold alloy obtained by
adding an element such as platinum (Pt), palladium (Pd), silver
(Ag), copper (Cu), iridium (Ir), zinc (Zn), indium (In), rhodium
(Rh), tin (Sn), and the like to gold.
[0011] In the above aspects of the present invention, the barrier
membrane for guided bone regeneration may further include a polymer
layer containing an antibiotic on an upper surface of the
substrate. In addition, the barrier membrane for guided bone
regeneration may further include a bio-ceramic layer obtained by
coating a lower surface of the substrate with bio-ceramic. In
addition, the bio-ceramic layer may be formed by coating the lower
surface of the substrate with a material selected from the group
consisting of hydroxyapatite (HA), .beta.-tricalcium phosphate
(.beta.-TCP), bioglass, and gypsum by spraying the material onto
the lower surface in high pressure. In addition, the bio-ceramic
layer may be made of a material selected from the group consisting
of hydroxyapatite (HA), .beta.-tricalcium phosphate (.beta.-TCP),
bioglass, and gypsum, and the bio-ceramic layer may be attached to
the lower surface of the substrate by using a polymer material
having adhesive force with the selected material.
[0012] In addition, the texture of the barrier membrane for guided
bone regeneration according to the first aspect may include a
plurality of protrusions and protruded pores, and the protruded
pores may pass through the upper and lower surfaces of the
substrate. In addition, the substrate of barrier membrane for
guided bone regeneration according to the above aspects may have
the previously set thickness and strength by being rolled.
ADVANTAGEOUS EFFECTS
[0013] It is possible to provide a barrier membrane having high
biocompatibility and space maintenance by making the barrier
membrane for guided bone regeneration with gold or silver. In
addition, the barrier membrane for guided bone regeneration is
constructed with a substrate made of silver, gold, or gold alloy.
It is possible to secure biocompatibility, exclusion and sealing of
cells, space maintenance, connectivity with tissues, and easiness
of using the barrier membrane by forming a polymer layer and a
bio-ceramic layer respectively on upper and lower surfaces of the
substrate. In addition, it is possible to prevent a flow of soft
tissues in a junction part with the soft tissues and minimize
bursts of sutures due to shrinkage of tissues by forming texture
including protrusions on the substrate according to an embodiment
of the present invention. In addition, it is possible for blood to
circulate by forming protruded pores on the substrate, thereby
supplying blood to epithelium cells.
[0014] Furthermore, the barrier membrane for guided tissue
regeneration according to an embodiment of the present invention
may be used to induce regeneration of bone tissues for orthopedic
or plastic surgery treatments, in addition to dental treatments.
Accordingly, the barrier membrane for guided tissue regeneration
may be used for various purposes.
DESCRIPTION OF DRAWINGS
[0015] FIG. 1 is a schematic diagram illustrating a structure of a
barrier membrane for guided tissue regeneration according to a
first embodiment of the present invention.
[0016] FIG. 2 is a schematic diagram illustrating a structure of a
barrier membrane for guided tissue regeneration according to a
second embodiment of the present invention.
[0017] FIG. 3 is a top plan view illustrating the barrier membrane
for guided bone regeneration having protrusions and protruded pores
according to the second embodiment of the present invention.
[0018] FIG. 4 includes cross sectional views taken along the
directions A-A' and B-B' of the barrier membrane for guided tissue
regeneration of FIG. 3.
[0019] FIG. 5 is a flowchart of an example of a procedure of
manufacturing the barrier membrane for guided bone regeneration
according to the second embodiment of the present invention.
BEST MODEL
First Embodiment
[0020] Hereinafter, a structure and an operation of a barrier
membrane for guided bone and tissue regeneration according to a
first embodiment of the present invention will be described with
reference to the attached drawings.
[0021] FIG. 1 is a schematic diagram illustrating a structure of a
barrier membrane for guided bone and tissue regeneration according
to a first embodiment of the present invention. Referring to FIG.
1, a barrier membrane 10 for guided bone and tissue regeneration
according to the first embodiment is constructed with a substrate
made of gold or silver having high purity so as to improve
biocompatibility and space maintenance or constructed with a
substrate made of gold alloy obtained by adding an element such as
platinum (Pt), palladium (Pd), silver (Ag), copper (Cu), iridium
(Ir), zinc (Zn), indium (In), rhodium (Rh), tin (Sn), and the like
to gold so as to improve strength and functions. Specifically, it
is possible to provide a barrier membrane with high space
maintenance in addition to high biocompatibility by using a
substrate made of a gold material for the barrier membrane.
[0022] In addition, the substrate may have a previously set
thickness through a rolling procedure. At this time, the previously
set thickness may range from 0.015 to 0.15 mm. The thickness of the
substrate has to be equal to or greater than 0.015 mm so as to
secure space maintenance of the barrier membrane. In addition, in
order to remove foreign body sensation due to the barrier membrane,
the thickness of the substrate may be equal to or less than 0.15
mm. If the thickness of the substrate of the barrier membrane is
greater than 0.15 mm, it is possible to secure space maintenance.
However, it is not easy to insert the barrier membrane. The barrier
membrane may cause damage of soft tissues. In addition, a tongue
may feel a foreign body under the soft tissues.
[0023] On the other hand, the barrier membrane according to the
first embodiment of the present invention effectively induces
regeneration of tissues of periodontal bone by further including a
bio-ceramic layer under the substrate. The lower surface of the
substrate is coated with the bio-ceramic layer by spraying
bio-ceramic onto the lower surface of the substrate in high
pressure. The bio-ceramic layer used for the barrier membrane
according to the current embodiment may be made of a bio-ceramic
material having a function of guiding regeneration of periodontal
bone tissues, such as hydroxyapatite (HA), .beta.-tricalcium
phosphate (.beta.-TCP), bioglass, gypsum, and the like.
[0024] In addition, the barrier membrane according to the first
embodiment of the present invention may further include a polymer
layer on the upper surface of the substrate. The polymer layer is
formed by coating the upper surface of the substrate with
bio-polymer solution containing an antibiotic. The antibiotic
contained in the polymer layer suppresses an inflammation and a
secondary infection which may occur after a surgical operation. The
antibiotic contained in the polymer layer of the barrier layer
according to an embodiment of the present invention may be
tetracycline.
Second Embodiment
[0025] Hereinafter, a structure and an operation of a barrier
membrane for guided bone and tissue regeneration according to a
second embodiment of the present invention will be described with
reference to FIGS. 2 to 4.
[0026] FIG. 2 is a schematic diagram illustrating a structure of a
barrier membrane for guided bone and tissue regeneration according
to a second embodiment of the present invention. FIGS. 3 and 4
include a top plan view and cross sectional views illustrating the
barrier membrane according to the second embodiment of the present
invention.
[0027] Referring to FIGS. 3 and 4, the barrier membrane 20 for
guided bone regeneration according to the first embodiment of the
present invention includes a substrate 230, a polymer layer 240
containing an antibiotic, and a bio-ceramic layer 250.
[0028] The substrate 230 is made of gold or silver having high
purity so as to improve biocompatibility and space maintenance or
made of gold alloy obtained by adding an element such as platinum
(Pt), palladium (Pd), silver (Ag), copper (Cu), iridium (Ir), zinc
(Zn), indium (In), rhodium (Rh), tin (Sn), and the like to gold so
as to improve strength and functions.
[0029] In FIG. 4, (a) is a cross sectional view taken along the
direction A-A' illustrating the barrier membrane of FIG. 3, and (b)
is a cross sectional view taken along the direction B-B'
illustrating the barrier membrane of FIG. 3. Referring to FIG. 4,
the substrate 230 has texture including a plurality of protrusions
200 and 210 and protruded pores 260. The barrier membrane for
guided bone and tissue regeneration according to the second
embodiment prevents a flow of soft tissues in a junction part with
the soft tissues by having the texture including hemispheric
protrusions. In addition, the barrier membrane according to the
second embodiment enables blood to be supplied to epithelial cells
by forming the protruded pores in the texture of the substrate.
[0030] On the other hand, although the texture including a
plurality of hemispheric protrusions is exemplified in the second
embodiment, it will be understood by those skilled in the art that
a plurality of cylindrical protrusions, a plurality of cone type
protrusions, or a plurality of polygonal solid protrusions may be
employed for the texture. In addition, in the barrier membrane
according to the second embodiment, the substrate may have various
types of texture in addition to the texture including the
protrusions and the protruded pores. For example, the substrate may
have texture including a plurality of through holes or texture
including only protrusions.
[0031] The lower surface of the substrate is coated with the
bio-ceramic layer 250 by spraying bio-ceramic onto the lower
surface of the substrate in high pressure so as to guide
regeneration of periodontal bone tissue. The bio-ceramic layer used
for the barrier membrane according to the second embodiment may be
made of a bio-ceramic material having a function of guiding
regeneration of periodontal bone tissue, such as hydroxyapatite
(HA), .beta.-tricalcium phosphate (.beta.-TCP), bioglass, gypsum,
and the like.
[0032] The polymer layer 240 is formed by coating the upper surface
of the substrate with bio-polymer solution containing an
antibiotic. The antibiotic contained in the polymer layer
suppresses an inflammation and a secondary infection which may
occur after a surgical operation. The antibiotic contained in the
polymer layer of the barrier layer according to an embodiment of
the present invention may be tetracycline.
[0033] Hereinafter, an example of a procedure of manufacturing the
barrier membrane 20 according to the second embodiment of the
present invention will be described with reference to FIG. 5.
[0034] First, strength of the substrate 230 is increased by rolling
the substrate 230 made of silver or gold having high purity or gold
alloy containing an element such as platinum (Pt), palladium (Pd),
silver (Ag), copper (Cu), iridium (Ir), zinc (Zn), indium (In),
rhodium (Rh), tin (Sn), and the like by using a roller to a
thickness ranging from 0.015 to 0.15 mm (operation 100).
[0035] Next, the substrate 230 has texture including hemispheric
protrusions 210 and 200 and protruded pores 260 by pressing the
substrate 230 (operation 110). Here, the texture is used to prevent
a flow of soft tissues such as gingival.
[0036] Hereinafter, the rolled substrate is cleansed by using an
ultrasonic cleaner (operation 120).
[0037] The upper and lower surfaces of the rolled substrate 230 are
sandblasted so as to be roughly processed (operation 130).
[0038] When the sandblasting process is completed, the upper
surface of the substrate having the texture 204 is spray-coated
with polymer solution containing an antibiotic so as to form the
polymer layer 240 containing the antibiotic on the upper surface of
the substrate (operation 140). Here, the polymer solution
containing the antibiotic is produced by mixing a solvent with
polymers to produce polymer solution and mixing the polymer
solution with an antibiotic such as tetracycline.
[0039] As described above, when the polymer layer 240 containing
the antibiotic is formed on the upper surface, the bio-ceramic
layer 250 is formed on the lower surface of the substrate 230 by
spraying a bio-ceramic such as hydroxyapatite (HA),
.beta.-tricalcium phosphate (.beta.-TCP), bioglass, gypsum, and the
like onto the lower surface of the substrate in high pressure and
plasma-coating the lower surface of the substrate with the
bio-ceramic (operation 150).
[0040] In addition, the bio-ceramic may be attached by using an
adhesive polymer material. Any bio-polymer material may be used as
the polymer material of for this case. Preferably, one of
polylactide-co-glycolide (PLGA), poly-L-lactic acid (PLLA),
polyglycolide (PGA), Cyanoacrylate may be employed as the polymer
material.
[0041] As described above, manufacturing of the barrier membrane
for guided tissue regeneration according to the second embodiment
is completed by forming the bio-ceramic layer 250 on the lower
surface of the substrate.
[0042] While the present invention has been particularly shown and
described with reference to exemplary embodiments thereof, it will
be understood by those skilled in the art that various changes in
form and details may be made therein without departing from the
spirit and scope of the present invention as defined by the
appended claims.
INDUSTRIAL APPLICABILITY
[0043] The barrier membrane for guided bone and tissue regeneration
according to an embodiment of the present invention may be used to
induce regeneration of bone tissues in orthopedic or plastic
surgery treatments, in addition to dental treatments. Accordingly,
the barrier membrane for guided bone and tissue regeneration may be
used for various purposes.
* * * * *